Prenatal 3D-Printed Orofacial Composite for Immediate Cleft Correction
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current pre-surgical correction methods for clefts in the orofacial area, such as presurgical nasoalveolar molding (PNAM), suffer from issues like irritation, fungal infections, asymmetric arch configurations, device breakage, and delayed application due to postnatal production, leading to facial discomfort, ineffective alimentation, and developmental delays.
Innovation Solution
A personalized medical device is created using prenatal additive manufacturing, utilizing CT, MRI, and 3D/4D ultrasound imaging to produce a multicomposite device with biocompatible materials, tailored to individual fetal anatomy, allowing immediate postnatal application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If postnatal production of medical devices is used, then manufacturing flexibility is improved, but time delay and developmental impacts worsen
Solution Approach 1:
The patent applies preliminary action by performing 3D printing of the medical device during the prenatal period, before birth. The device is manufactured in advance using prenatal imaging data, then immediately applied postnatally. This eliminates the traditional postnatal production time delay while maintaining manufacturing flexibility through digital design and additive manufacturing capabilities.
2Ease of operation
If traditional PNAM devices are used, then correction function is provided, but facial discomfort and irritation worsen
Solution Approach 1:
The patent applies local quality by creating a personalized medical device with customized geometry and material properties specifically adapted to the patient's unique anatomy. The device features localized pressure distribution, customized fit, and personalized characteristics that reduce overall facial discomfort while maintaining effective correction function. Each device is uniquely tailored to the individual patient rather than using a generic design.
Solution Approach 2:
The patent employs composite materials by using a multilayer structure combining rigid support layers with flexible cushioning layers. This composite construction allows the device to provide structural correction while simultaneously reducing facial discomfort through the flexible elements that distribute pressure more evenly across the patient's face.
3Strength
If single-composite palate replacement is used, then structural support is provided, but sealing effectiveness and vector mechanics worsen
Solution Approach 1:
The patent applies segmentation by dividing the single-composite palate replacement into multiple separate functional components or layers. Each segment can be optimized for its specific function - some layers provide structural support while others provide sealing. This modular approach allows independent optimization of sealing effectiveness and structural strength without compromising either function.
Solution Approach 2:
The patent uses composite materials to create a multilayer structure where different materials with different properties are combined. Rigid materials provide structural support while flexible materials provide sealing effectiveness. This composite construction resolves the contradiction by allowing each material to optimize its specific function while working together as an integrated system.
4Ease of manufacture
If non-personalized devices are used, then manufacturing simplicity is maintained, but adaptability to individual anatomy worsens
Solution Approach 1:
The patent applies copying by using 3D scanning and digital modeling to create a precise virtual copy of the patient's unique anatomy. This digital model serves as the basis for generating the personalized device through additive manufacturing. The copying process captures all anatomical details, allowing the device to be perfectly adapted to the individual patient while still using automated digital manufacturing processes.
Solution Approach 2:
The patent employs parameter changes by digitally adjusting multiple geometric parameters of the device based on the patient's specific anatomical measurements. The manufacturing process involves modifying parameters such as dimensions, curvature, thickness, and shape to match the individual patient's anatomy. This allows high adaptability while maintaining manufacturing simplicity through automated digital parameter adjustment rather than manual customization.
Data Source
AI summary
A personalized medical device intended for correction of defects, in particular in the orofacial area is multicomposite and comprises a hard tissue replacement and a soft tissue replacement. The hard tissue replacement is a hard core of biocompatible thermoplastic material and the soft tissue replacement is a biocompatible elastic substance. Preparation of personalized medical device even in the prenatal period using CT, MRI and 3D/4D electronic USG imaging and “additive manufacturing” technology.